Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/30/2019
Start Date:June 17, 2015
End Date:July 29, 2020
Contact:Receptos True North Study
Email:truenorth@quintiles.com
Phone:1-844-266-9299

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

The purpose of this study is to determine whether RPC1063 is effective in the treatment of
Ulcerative Colitis (UC).

The trial is composed of 2 periods: Induction and Maintenance. Patients will be entered into
the trial in 2 separate cohorts through the Induction Period (10 weeks) and those patients in
clinical response at the end of the Induction Period will proceed through to the Maintenance
Period. Participation in these periods will be 52 weeks. Patients may also qualify to
participate in an optional Open-Label Extension study.

Key Inclusion Criteria:

- Ulcerative Colitis (UC) confirmed on endoscopy

- Moderately to severely active UC (Mayo score 6-12)

- Currently receiving treatment with aminosalisylate, prednisone, or budesonide

Key Exclusion Criteria:

- Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a
fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or
ischemic colitis

- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk

- History of uveitis macular edema

- Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG)
measured during Screening
We found this trial at
111
sites
Anaheim Clinical Trials, LLC
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
17
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Anaheim, CA
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
2438
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Bronx, NY
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
2189
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Chapel Hill, NC
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Gastroenterology Associates of Tidewater
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
2340
mi
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Chesapeake, VA
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Brooke Army Medical Center
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
1190
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Indiana University Hospital
550 University Boulevard
Indianapolis, Indiana 46202
1792
mi
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Indianapolis, IN
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Kinston Medical Specialists
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
2282
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Kinston, NC
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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
1881
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Lexington, KY
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
1762
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Nashville, TN
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Hospital of the University of Pennsylvania
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
2373
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
827
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Portland, OR
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
572
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Gastroenterology, Ltd.
1101 First Colonial Road
Virginia Beach, Virginia 23454
757-481-4817
2351
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Virginia Beach, VA
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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1932
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Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina 28801
2002
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Asheville, NC
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
1918
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Atlanta, GA
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University of Maryland Medical Group
22 South Greene Street
Baltimore, Maryland 21201
2301
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Baltimore, MD
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Johns Hopkins Clinical Research Network
1800 Orleans Street
Baltimore, Maryland 21287
2302
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Woodholme Gastroenterology
Baltimore, Maryland 21208
2301
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Baltimore, MD
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
1589
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Baton Rouge, LA
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
1341
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Belton, MO
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Boston Med Ctr
Boston, Massachusetts 02118
2577
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Boston, MA
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Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton, Missouri 63044
1562
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
2581
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NY Scientific
2001 Oriental Boulevard
Brooklyn, New York 11235
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Hospital Italiano
4190 Juan D. Peron
Buenos Aires, C1181
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Buenos Aires,
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Carolinas HealthCare System Digestive Health
1025 Morehead Medical Drive
Charlotte, North Carolina 28204
2102
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
2278
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Chevy Chase, MD
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Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago, Illinois 60611
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
1730
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
1882
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Clinical Research of West Florida - Clearwater
Clearwater, Florida 33765
2116
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Clearwater, FL
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Gastro Florida
Clearwater, Florida 33762
2124
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Gastro Center of Maryland
Columbia, Maryland 21045
2289
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Consultants in Gastroenterology
Columbia, South Carolina 29203
2105
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Ohio State University Clinical Trials Management Office
Columbus, Ohio
1960
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Aurora Care Clinic
Costa Mesa, California 92627
29
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Baylor Research Institute
3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Advanced Pharma Research, Inc
Delray Beach, Florida 33445
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Dolphin Medical Research
Doral, Florida 33172
2311
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Universal Axon Clinical Research, LLC
3650 Northwest 82nd Avenue
Doral, Florida 33166
2313
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Ventavia Research Group, LLC
Fort Worth, Texas 76104
1195
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Valley View Internal Medicine
Garden Grove, California 92843
21
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Gastro One
Germantown, Tennessee 38138
1600
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Long Island Clinical Research Associates
Great Neck, New York 11021
2447
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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Gulf Coast Research Group LLC
Houston, Texas 77004
1358
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The Methodist Hospital Research Institute
Houston, Texas 77030
1357
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Houston Endoscopy and Research Center
Houston, Texas 77079
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Davita Clinical Trials, LLC
Huntington Beach, California 92646
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Grand Teton Research Group
Idaho Falls, Idaho 83404
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East Carolina Gastroenterology
Jacksonville, North Carolina 28546
2298
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University of California, San Diego Medical Center
La Jolla, California 92093
99
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Om Research
Lancaster, California 93534
43
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Florida Center for Gastroenterology
Largo, Florida 33777
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Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
2514
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Gastrointestinal Biosciences
Los Angeles, California 90067
22
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Southern California Research Institute Medical Group Inc
Los Angeles, California 90045
13
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University of Southern California- Keck School of Medicine
Los Angeles, California 90033
11
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University of Louisville
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Dean Foundation for Health, Research and Education Inc.
Madison, Wisconsin 53715
1656
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
1908
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Marietta, GA
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Community Clinical Research Network
Marlborough, Massachusetts 01752
2553
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Great Lakes Gastroenterology Research
Mentor, Ohio 44060
2051
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Mentor, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
2320
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Advanced Clinical Research of Miami
Miami, Florida 33155
2316
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Regenerate Clinical Trials
Miami, Florida 33155
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Advanced Clincial Research
Miami, Florida 33134
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Facey Medical Foundation (Parent)
15451 San Fernando Mission Boulevard
Mission Hills, California 91345
29
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Advanced Research for Health Improvement, LLC
1168 Goodlette-Frank Road
Naples, Florida 34102
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Advanced Research Institute, Inc
New Port Richey, Florida
2118
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NSB Research
New Smyrna Beach, Florida 32174
2201
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Icahn School of Medicine Mount Sinai Beth Isreal
New York, New York 10003
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Weill-Cornell Medical College
New York, New York 10021
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Mount Sinai - PRIME
New York, New York 10029
2435
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Concord Medical Group PRIME
New York, New York 10016
2351
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New York University School of Medicine
550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
2434
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Arkansas Gastroenterology
North Little Rock, Arkansas
1464
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Med-Care Research
North Miami Beach, Florida 33162
2318
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Harmony Clinical Research, Inc.
North Miami Beach, Florida 33162
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DM Clinical Research
Oak Lawn, Illinois 60453
1721
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Alliance Clinical Research
Oceanside, California 92056
73
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University of Oklahoma
1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
1165
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
1161
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Gastroenterology Associates of Orangeburg, PA
Orangeburg, South Carolina 29118
2122
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Center For Digestive Health
Orlando, Florida 32803
2184
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IMIC
Palmetto Bay, Florida
2318
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Theia Clinical Research
4820 Park Boulevard North
Pinellas Park, Florida 33781
2125
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The Mayo Clinic
Rochester, Minnesota 55905
1524
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PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina 27804
2263
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Washington University
Saint Louis, Missouri 63110
1568
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Clinical Research Professionals LLC - The Pines Court
Saint Louis, Missouri 63141
1573
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Clinical Research Professionals, LLC - Olde Cabin Rd
11457 Olde Cabin Road
Saint Louis, Missouri 63141
1560
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Gastroenterology Research Of San Antonio
San Antonio, Texas 78229
1188
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San Antonio Gastroenterology
520 East Euclid Avenue
San Antonio, Texas 78212
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Medical Associates Research Group
San Diego, California 92123
101
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University of California at San Francisco (PARENT)
1710 Scott Street
San Francisco, California 94115
356
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University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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964
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Benaroya Research Institute at Virginia Mason
Seattle, Washington 98101
961
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Texas Digestive Disease Consultants - Southlake
505 Nolen Drive
Southlake, Texas 76092
1204
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